Before research involving humans can commence, the ethical aspects of the research study are reviewed by local ethics boards in the United States known as Institutional Review Boards (IRBs). IRBs review many factors surrounding the ethics of research involving humans, including whether the science is valid, there is a favorable benefit-to-risk ratio, participants are recruited fairly and have retained the right to withdraw from research, privacy is protected, and the informed consent process will be performed such that participants are fully informed and understand the nature of the study. IRBs are located within institutions that perform human research such as universities and colleges, research centers, government agencies, and others. IRBs consist of individuals with a diversity of scientific, clinical, ethics, and legal expertise. The advantage of performing ethics review at the local level is that IRB members know their community, including the prevalence of health issues and the average educational level allowing them to be able to effectively communicate with community members and ensure they can access beneficial research. As trust is an essential element to voluntary community participation, an absence of it might lead to decreased enrolment in clinical trials. Knowing that a body of experts has reviewed the ethical aspects of research is likely to promote trust between participants and the research institution.

While local review certainly has its advantages, more research is being performed at multiple institutions, such as large phase 3 and 4 clinical trials that can be performed at dozens of research sites across the country. Currently, this means that researchers will have to submit their protocol to every individual IRB for approval. Several studies surrounding multisite ethics review have been performed and many question whether a more efficient system cannot be developed. Below we discuss some of the issues with multisite ethics review and outline a few reform strategies.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

There is a cultural perception that women are very likely to cause fetal harm, reflected in limitations on women’s participation in clinical trials and certain jobs, public service announcements telling women not to drink alcohol while pregnant, and extensive media coverage of ‘‘crack babies.’’ The long history of the medical realm treating women’s bodies as weak, permeable, and inherently diseased contributes to the worry that women’s bodies will ‘‘infect’’ fetuses. Men’s bodies, in contrast, are as seen as stable, bound, and healthy; therefore, they are not a risk to fetuses. However, this belief is scientifically inaccurate. Men’s behaviors and characteristics can cause paternal-fetal harm. For instance, paternal smoking and drinking can result in an increased chance of birth defects and low birth weight. Paternal use of illegal drugs (such as cocaine, hashish, opium, and heroin) can also lead to fetal health problems because of abnormal sperm. Additionally, older paternal age has been associated with a higher risk of children with autism, Down syndrome, and schizophrenia.

Despite these scientific facts, there is little public and academic discussion of men and fetal harm, which implies that men do not (or cannot) cause such harm. The cultural narrative that men are not causally or ethically responsible for fetal harm has been reified in law, policy, medicine, and the media. Even the language we use to discuss reproduction and childcare minimizes the role men play in reproduction. The verb “to father” is synonymous with ‘‘to sire’’ and refers to impregnating a woman, that is, the one time event of fertilization. In contrast, “to mother” refers to constant caregiving and nurturing.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

Over the past few decades, clinical ethics consultations have become an important component in providing quality care in cases where there are value conflicts that must be resolved before viable goals of healthcare can be accomplished. With the development of this service and its acceptance as a necessary part of patient care, questions arise as to how and when will clinical ethics consultation be recognized as a specialized professional service comparable to medicine, nursing, social work and pastoral care? For physicians, nurses, social workers, and chaplains there are well-established pathways for practitioners to take in each of these areas in order to be recognized as fully qualified professionals. There is no such pathway to date for those individuals who provide clinical ethics consultations. For those of us who have been involved in this area it is interesting to reflect upon the vast improvements made in providing clinical ethics consultations and whether the field is ready for professionalization.

I recall my early years of training in medical ethics as a graduate student in philosophy at the University of Tennessee. As part of the requirements for the PhD in philosophy with a concentration in medical ethics, students had to spend 3 months at the Health Science Center in Memphis where we participated in intensive internship in medical ethics. At that time I was fortunate to have one of the early pioneers in medical ethics as a mentor, Professor David Thomasma, who was beginning to do clinical ethics consultations. During the 1970’s philosophers and others in fields pertaining to ethics were being invited to enter the medical setting to help physicians and nurses grapple with some of the ethical dilemmas that were becoming more evident with the increasing use of dialysis machines and mechanical life supports. There seemed to be an assumption, perhaps naïve in retrospect, that philosophers like professor Thomasma and others had some special understanding of ethical issues that would shed light on the emerging medical ethical dilemmas and therefore would be in a position to give helpful advice.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

Last month, a New Mexico trial court judge ruled that a terminally ill patient had a constitutionally protected right to aid in dying from a physician without risking criminal prosecution for assisted suicide. Judge Nan G. Nash of the Second District Court in Albuquerque based her opinion in the New Mexico Constitution: “This court cannot envision a right more fundamental, more private or more integral to the liberty, safety and happiness of a New Mexican than the right of a competent, terminally ill patient to choose aid in dying.” Thus, the state became the fifth to permit physician-assisted suicide, following Oregon (1997, approved by voter referendum), Washington (2006, approved by voter referendum), Montana (2009, allowed by state supreme court opinion), and Vermont (2013, enacted by the state legislature).

The case was brought by two oncologists (Drs. Katherine Morris and Aroop Mangalik) who asked the court to clarify the state’s assisted suicide law and allow them write a lethal dose of a drug for a 49-year-old patient (Aja Riggs) with advanced uterine cancer. Critical to the case may have been the December trial testimony from the patient: “I don’t want to suffer needlessly at the end.”

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

During a long cold drive home a couple weeks ago, there was a broadcast on NPR about efforts to help promote the survival of the rare northern spotted owl. The controversy has not centered on the importance of saving the spotted owl, but on whether or not it is ethically acceptable to hunt the barred owl which has moved into territory thereby dangerously threatening the spotted owl population. The barred owl is also an “at risk” species, but has been thriving in the northwestern forests where the spotted owls had fed, bred, and nested. The government faced a “Sophie’s choice” (Shogran 2014, NPR), and reluctantly accepted the morally disturbing decision to kill 3600 barred owls in order to try to help the spotted owl maintain a sustainable population. This distressing environmental dilemma serves as a unique analogy for responsible business decisions related to healthcare. We can turn to business ethics here, which offers the “precautionary principle” (Weber 2001, 134) whereby avoiding harm and meeting the needs of a community requires that if any deleterious action is going to be taken, the proponents of the activity must establish that safety is the intent and there is no other way to accomplish the task than to inflict some degree of harm. Though the cause of reduced numbers of spotted owls and the migration of barred owls is related to man’s stripping timber from the natural habitats of each, the solution needs to balance the competing interests in the existing ecosystem. Similarly, people seeking healthcare in the US are not to blame for the economic woes of our system but it seems compromises from everyone will be needed in order to assure a basic level of service for all.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

I have written before on the subject of stupidity in government. In most cases I have focused on the federal government and, in particular, the parts of congress that make science policy including the funding and regulation of those agencies in the federal government which fund scientific research. However, the stupidity of government is not limited to the federal. Today I will discuss the stupidity governing several states regarding what is allowed to pass as scientific education. Unlike scientific research where most public financial support and policy oversight comes from the federal government, the public support for education and education policy comes primarily from the states. Chris Kirk writing in Slate has recently described the state-by-state distribution of publically funded education that includes the teaching of creationism in science curricula.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.